Trial Outcomes & Findings for A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (NCT NCT03207867)

NCT ID: NCT03207867

Last Updated: 2024-10-09

Results Overview

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

315 participants

Primary outcome timeframe

Up to 3.9 years

Results posted on

2024-10-09

Participant Flow

Participants took part in 21 investigative sites in 15 countries.

The screening period began once patients had signed the study informed consent. Screening evaluations had to be completed within 21 days prior to the first dose of treatment except for the radiological tumor assessment which had to be performed within 28 days prior to the first dose. After screening, the treatment period started on Cycle 1 Day 1.

Participant milestones

Participant milestones
Measure
Part 1: RCC naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: H-N Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: MSS CRC Unk 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: DLBCL 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: DLBCL 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Overall Study
STARTED
11
12
11
14
14
15
11
12
27
29
2
30
3
13
13
6
15
22
20
20
6
3
3
3
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
11
12
11
14
14
15
11
12
27
29
2
30
3
13
13
6
15
22
20
20
6
3
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1: RCC naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: H-N Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: MSS CRC Unk 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: DLBCL 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: DLBCL 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Overall Study
Adverse Event
1
0
1
0
0
2
1
1
2
2
0
0
0
0
0
0
3
1
2
1
0
0
0
0
Overall Study
Death
0
0
0
0
0
1
0
3
1
2
0
1
0
1
0
0
0
2
0
1
0
0
0
0
Overall Study
Physician Decision
3
5
0
3
2
0
0
0
4
2
0
4
0
0
2
1
1
2
1
3
0
0
0
0
Overall Study
Progressive Disease
7
7
9
10
11
10
9
8
19
23
2
24
3
11
9
5
10
14
13
14
6
3
3
3
Overall Study
Patient/guardian Decision
0
0
1
1
1
2
1
0
1
0
0
1
0
1
2
0
1
3
4
1
0
0
0
0

Baseline Characteristics

A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: H-N Pre 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: MSS CRC Unk 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: DLBCL 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: DLBCL 240 mg
n=6 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg Cont
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
n=3 Participants
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
n=3 Participants
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Total
n=315 Participants
Total of all reporting groups
Race/Ethnicity, Customized
White
9 Participants
n=5 Participants
3 Participants
n=7 Participants
10 Participants
n=5 Participants
13 Participants
n=4 Participants
5 Participants
n=21 Participants
14 Participants
n=10 Participants
9 Participants
n=115 Participants
12 Participants
n=24 Participants
20 Participants
n=42 Participants
23 Participants
n=42 Participants
2 Participants
n=42 Participants
21 Participants
n=42 Participants
1 Participants
n=36 Participants
13 Participants
n=36 Participants
7 Participants
n=24 Participants
0 Participants
n=135 Participants
13 Participants
n=136 Participants
10 Participants
n=44 Participants
7 Participants
n=667 Participants
7 Participants
n=7 Participants
1 Participants
n=6 Participants
0 Participants
n=10 Participants
0 Participants
n=14 Participants
0 Participants
n=4 Participants
200 Participants
n=4 Participants
Age, Continuous
65.5 years
STANDARD_DEVIATION 10.86 • n=5 Participants
60.0 years
STANDARD_DEVIATION 11.96 • n=7 Participants
60.6 years
STANDARD_DEVIATION 8.54 • n=5 Participants
60.4 years
STANDARD_DEVIATION 8.98 • n=4 Participants
66.9 years
STANDARD_DEVIATION 9.63 • n=21 Participants
61.6 years
STANDARD_DEVIATION 7.13 • n=10 Participants
59.4 years
STANDARD_DEVIATION 9.05 • n=115 Participants
60.2 years
STANDARD_DEVIATION 7.07 • n=24 Participants
56.5 years
STANDARD_DEVIATION 9.04 • n=42 Participants
58.1 years
STANDARD_DEVIATION 11.21 • n=42 Participants
46.0 years
STANDARD_DEVIATION 15.56 • n=42 Participants
49.8 years
STANDARD_DEVIATION 10.81 • n=42 Participants
50.3 years
STANDARD_DEVIATION 20.65 • n=36 Participants
54.2 years
STANDARD_DEVIATION 14.87 • n=36 Participants
55.0 years
STANDARD_DEVIATION 18.65 • n=24 Participants
61.5 years
STANDARD_DEVIATION 13.10 • n=135 Participants
68.3 years
STANDARD_DEVIATION 8.14 • n=136 Participants
65.0 years
STANDARD_DEVIATION 9.02 • n=44 Participants
61.8 years
STANDARD_DEVIATION 9.51 • n=667 Participants
64.2 years
STANDARD_DEVIATION 8.94 • n=7 Participants
58.5 years
STANDARD_DEVIATION 16.16 • n=6 Participants
61.3 years
STANDARD_DEVIATION 10.69 • n=10 Participants
57.0 years
STANDARD_DEVIATION 9.54 • n=14 Participants
44.3 years
STANDARD_DEVIATION 8.33 • n=4 Participants
59.5 years
STANDARD_DEVIATION 11.59 • n=4 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
2 Participants
n=10 Participants
3 Participants
n=115 Participants
3 Participants
n=24 Participants
9 Participants
n=42 Participants
8 Participants
n=42 Participants
1 Participants
n=42 Participants
30 Participants
n=42 Participants
1 Participants
n=36 Participants
3 Participants
n=36 Participants
7 Participants
n=24 Participants
3 Participants
n=135 Participants
0 Participants
n=136 Participants
7 Participants
n=44 Participants
7 Participants
n=667 Participants
8 Participants
n=7 Participants
6 Participants
n=6 Participants
3 Participants
n=10 Participants
1 Participants
n=14 Participants
1 Participants
n=4 Participants
119 Participants
n=4 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
12 Participants
n=7 Participants
9 Participants
n=5 Participants
8 Participants
n=4 Participants
9 Participants
n=21 Participants
13 Participants
n=10 Participants
8 Participants
n=115 Participants
9 Participants
n=24 Participants
18 Participants
n=42 Participants
21 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=36 Participants
10 Participants
n=36 Participants
6 Participants
n=24 Participants
3 Participants
n=135 Participants
15 Participants
n=136 Participants
15 Participants
n=44 Participants
13 Participants
n=667 Participants
12 Participants
n=7 Participants
0 Participants
n=6 Participants
0 Participants
n=10 Participants
2 Participants
n=14 Participants
2 Participants
n=4 Participants
196 Participants
n=4 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
0 Participants
n=7 Participants
0 Participants
n=6 Participants
3 Participants
n=10 Participants
3 Participants
n=14 Participants
3 Participants
n=4 Participants
10 Participants
n=4 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
8 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
8 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
6 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
2 Participants
n=36 Participants
0 Participants
n=36 Participants
4 Participants
n=24 Participants
6 Participants
n=135 Participants
2 Participants
n=136 Participants
11 Participants
n=44 Participants
13 Participants
n=667 Participants
12 Participants
n=7 Participants
0 Participants
n=6 Participants
0 Participants
n=10 Participants
0 Participants
n=14 Participants
0 Participants
n=4 Participants
78 Participants
n=4 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
0 Participants
n=7 Participants
0 Participants
n=6 Participants
0 Participants
n=10 Participants
0 Participants
n=14 Participants
0 Participants
n=4 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
1 Participants
n=44 Participants
0 Participants
n=667 Participants
0 Participants
n=7 Participants
3 Participants
n=6 Participants
0 Participants
n=10 Participants
0 Participants
n=14 Participants
0 Participants
n=4 Participants
5 Participants
n=4 Participants
Race/Ethnicity, Customized
Unknown
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
5 Participants
n=42 Participants
0 Participants
n=42 Participants
7 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
2 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
1 Participants
n=7 Participants
2 Participants
n=6 Participants
0 Participants
n=10 Participants
0 Participants
n=14 Participants
0 Participants
n=4 Participants
21 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
27.3 percentage of participants
Interval 7.9 to 56.4
25.0 percentage of participants
Interval 7.2 to 52.7
0 percentage of participants
Interval 0.0 to 23.8
0 percentage of participants
Interval 0.0 to 19.3
7.1 percentage of participants
Interval 0.4 to 29.7
13.3 percentage of participants
Interval 2.4 to 36.3
0 percentage of participants
Interval 0.0 to 23.8
0 percentage of participants
Interval 0.0 to 10.5
3.4 percentage of participants
Interval 0.2 to 15.3
10.0 percentage of participants
Interval 2.8 to 23.9
0 percentage of participants
Interval 0.0 to 20.6
0 percentage of participants
Interval 0.0 to 18.1

PRIMARY outcome

Timeframe: Up to 2.5 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL). For Cheson 2014 criteria, CR= Target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi), no extralymphatic sites of disease, absent non-measured lesions, organ enlargement regress to normal, no new lesions, and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative); PR= ≥50% decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes, absent or regressed non-measured lesions, spleen must have regressed by \>50% in length beyond normal, and no new lesions.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Overall Response Rate (ORR) Per Cheson 2014 for DLBCL
15.4 percentage of participants
Interval 2.8 to 41.0

PRIMARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
9.1 percentage of participants
Interval 1.6 to 25.9
0 percentage of participants
Interval 0.0 to 13.9
10.0 percentage of participants
Interval 1.8 to 28.3

PRIMARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
16.7 percentage of participants
Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
36.4 percentage of participants
Interval 13.5 to 65.0
25.0 percentage of participants
Interval 7.2 to 52.7
0 percentage of participants
Interval 0.0 to 23.8
0 percentage of participants
Interval 0.0 to 19.3
7.1 percentage of participants
Interval 0.4 to 29.7
13.3 percentage of participants
Interval 2.4 to 36.3
0 percentage of participants
Interval 0.0 to 23.8
0 percentage of participants
Interval 0.0 to 10.5
3.4 percentage of participants
Interval 0.2 to 15.3
10.0 percentage of participants
Interval 2.8 to 23.9
0 percentage of participants
Interval 0.0 to 20.6
0 percentage of participants
Interval 0.0 to 18.1

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
9.1 percentage of participants
Interval 1.6 to 25.9
5.0 percentage of participants
Interval 0.3 to 21.6
15.0 percentage of participants
Interval 4.2 to 34.4

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
16.7 percentage of participants
Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Baseline, up to 0.8 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the prostate cancer group defined in the study protocol for efficacy assessment: mCRPC 240 mg

Prostate-specific antigen (PSA) levels were assessed in serum. Rising PSA is generally a manifestation of progression of prostate cancer.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Mean Percentage Change in PSA From Baseline
214.46 percentage change in PSA from baseline
Standard Deviation 329.459

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
54.5 percentage of participants
Interval 27.1 to 80.0
66.7 percentage of participants
Interval 39.1 to 87.7
18.2 percentage of participants
Interval 3.3 to 47.0
0 percentage of participants
Interval 0.0 to 19.3
28.6 percentage of participants
Interval 10.4 to 54.0
40.0 percentage of participants
Interval 19.1 to 64.0
63.6 percentage of participants
Interval 35.0 to 86.5
25.9 percentage of participants
Interval 12.9 to 43.2
17.2 percentage of participants
Interval 7.0 to 32.9
33.3 percentage of participants
Interval 19.3 to 49.9
0 percentage of participants
Interval 0.0 to 20.6
46.7 percentage of participants
Interval 24.4 to 70.0

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
63.6 percentage of participants
Interval 35.0 to 86.5
66.7 percentage of participants
Interval 39.1 to 87.7
18.2 percentage of participants
Interval 3.3 to 47.0
0 percentage of participants
Interval 0.0 to 19.3
35.7 percentage of participants
Interval 15.3 to 61.0
40.0 percentage of participants
Interval 19.1 to 64.0
54.5 percentage of participants
Interval 27.1 to 80.0
25.9 percentage of participants
Interval 12.9 to 43.2
13.8 percentage of participants
Interval 4.9 to 28.8
36.7 percentage of participants
Interval 22.1 to 53.3
0 percentage of participants
Interval 0.0 to 20.6
46.7 percentage of participants
Interval 24.4 to 70.0

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Disease Control Rate (DCR) Per Cheson 2014 for DLBCL
23.1 percentage of participants
Interval 6.6 to 49.5

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
36.4 percentage of participants
Interval 19.6 to 56.1
40.0 percentage of participants
Interval 21.7 to 60.6
35.0 percentage of participants
Interval 17.7 to 55.8

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
36.4 percentage of participants
Interval 19.6 to 56.1
45.0 percentage of participants
Interval 25.9 to 65.3
45.0 percentage of participants
Interval 25.9 to 65.3

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
16.7 percentage of participants
Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
16.7 percentage of participants
Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 for whom best overall response was CR or PR and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 for whom best overall response was iCR or iPR and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=4 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Duration Of Response (DOR) Per iRECIST for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: All patients from Part 1 for whom best overall response was CR or PR and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per Cheson 2014 criteria for DLBCL. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Duration Of Response (DOR) Per Cheson 2014 for DLBCL
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 for whom best overall response was CR or PR

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=2 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 for whom best overall response was iCR or iPR

DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=1 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Duration Of Response (DOR) Per iRECIST for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 for whom best overall response was CR or PR

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 for whom best overall response was iCR or iPR

DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Duration Of Response (DOR) Per iRECIST for Solid Tumors
NA months
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
3.5 months
Interval 1.9 to 15.4
7.2 months
Interval 1.8 to 8.6
1.9 months
Interval 1.7 to 2.0
1.7 months
Interval 1.6 to 1.7
1.9 months
Interval 1.7 to 3.5
2.0 months
Interval 1.6 to 3.7
3.5 months
Interval 1.7 to 3.7
1.7 months
Interval 1.6 to 1.9
1.9 months
Interval 1.7 to 2.0
1.7 months
Interval 1.6 to 1.9
1.8 months
Interval 1.6 to 1.9
3.7 months
Interval 1.7 to 5.3

SECONDARY outcome

Timeframe: Up to 3.9 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
8.7 months
Interval 2.1 to
Not estimable due to insufficient number of participants with events
7.2 months
Interval 1.8 to
Not estimable due to insufficient number of participants with events
1.9 months
Interval 1.7 to 2.0
1.7 months
Interval 1.1 to 1.7
2.1 months
Interval 1.7 to 3.5
2.0 months
Interval 1.6 to 3.7
3.5 months
Interval 1.7 to 3.7
1.8 months
Interval 1.6 to 2.0
1.9 months
Interval 1.7 to 2.0
1.8 months
Interval 1.6 to 3.5
1.8 months
Interval 1.6 to 1.9
3.7 months
Interval 1.7 to 5.3

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Cheson 2014 for DLBCL. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Progression-Free Survival (PFS) Per Cheson 2014 for DLBCL
1.7 months
Interval 1.4 to 2.2

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
2.0 months
Interval 1.8 to 3.8
2.1 months
Interval 1.7 to 3.7
1.9 months
Interval 1.7 to 3.7

SECONDARY outcome

Timeframe: Up to 4.7 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
2.1 months
Interval 1.8 to 3.8
2.2 months
Interval 1.8 to 3.7
2.8 months
Interval 1.7 to 9.0

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
1.6 months
Interval 0.9 to 1.8

SECONDARY outcome

Timeframe: Up to 0.5 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST. PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
1.6 months
Interval 0.9 to 1.8

SECONDARY outcome

Timeframe: 2 years

Population: All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected cancer groups defined in the protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg, DLBCL 160 mg and mCRPC 240 mg

OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan (SAP).

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=11 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=15 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=29 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=13 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: 2-year Overall Survival (OS)
63.6 percentage of participants
Interval 35.5 to 82.1
42.1 percentage of participants
Interval 14.6 to 67.8
27.3 percentage of participants
Interval 8.9 to 49.8
NA percentage of participants
Not estimable due to insufficient number of participants with events
36.1 percentage of participants
Interval 15.0 to 57.9
33.3 percentage of participants
Interval 15.0 to 52.9
15.3 percentage of participants
Interval 1.9 to 41.2
22.1 percentage of participants
Interval 9.4 to 38.2
14.3 percentage of participants
Interval 4.3 to 29.9
30.8 percentage of participants
Interval 16.0 to 46.9
NA percentage of participants
Not estimable due to insufficient number of participants with events
23.1 percentage of participants
Interval 7.5 to 43.6
31.4 percentage of participants
Interval 10.8 to 54.7

SECONDARY outcome

Timeframe: 2 years

Population: All patients from Part 2 who were randomized to the study treatment dosing schedule.

OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=22 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: 2-year Overall Survival (OS)
33.6 percentage of participants
Interval 15.5 to 52.9
22.7 percentage of participants
Interval 7.5 to 42.7
39.7 percentage of participants
Interval 20.3 to 58.6

SECONDARY outcome

Timeframe: 2 years

Population: All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.

OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: 2-year Overall Survival (OS)
NA percentage of participants
Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.

Population: All patients from Part 1 who received any study drug, had paired tumor samples, had a valid assessment for the outcome measure and were included in the selected cancer groups defined in the protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg, DLBCL 160 mg and mCRPC 240 mg

The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=5 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=5 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=4 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=7 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=9 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=10 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=4 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=1 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=4 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
10.93 CD8 percent marker area
Standard Deviation 14.227
10.53 CD8 percent marker area
Standard Deviation 12.456
0.70 CD8 percent marker area
Standard Deviation 2.645
-0.81 CD8 percent marker area
Standard Deviation 0.537
0.96 CD8 percent marker area
Standard Deviation 1.345
1.63 CD8 percent marker area
Standard Deviation 2.372
-0.42 CD8 percent marker area
Standard Deviation 1.477
0.70 CD8 percent marker area
Standard Deviation 1.141
-0.01 CD8 percent marker area
Standard Deviation 1.164
4.86 CD8 percent marker area
Standard Deviation 3.751
0.16 CD8 percent marker area
Standard Deviation 0.540
7.84 CD8 percent marker area
2.67 CD8 percent marker area
Standard Deviation 4.156

SECONDARY outcome

Timeframe: Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.

Population: All patients from Part 2 who received any study drug, had paired tumor samples and had a valid assessment for the outcome measure

The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=4 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=4 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 2: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
3.81 CD8 percent marker area
Standard Deviation 4.551
-2.35 CD8 percent marker area
Standard Deviation 5.586
1.23 CD8 percent marker area
Standard Deviation 2.955

SECONDARY outcome

Timeframe: Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.

Population: All patients from Part 3 who received any study drug, had paired tumor samples and had a valid assessment for the outcome measure

The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 3: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
0.26 CD8 percent marker area

SECONDARY outcome

Timeframe: Up to 4 years (Part 1), 4.8 years (Part 2) and 0.6 years (Part 3)

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
SAEs
3 Participants
7 Participants
9 Participants
7 Participants
15 Participants
5 Participants
28 Participants
11 Participants
3 Participants
6 Participants
0 Participants
4 Participants
11 Participants
7 Participants
7 Participants
3 Participants
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related SAEs
0 Participants
2 Participants
2 Participants
1 Participants
3 Participants
2 Participants
7 Participants
2 Participants
0 Participants
2 Participants
0 Participants
2 Participants
6 Participants
3 Participants
0 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Fatal SAEs
1 Participants
0 Participants
1 Participants
0 Participants
2 Participants
1 Participants
3 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
2 Participants
0 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
AEs
10 Participants
22 Participants
14 Participants
14 Participants
26 Participants
12 Participants
57 Participants
29 Participants
15 Participants
13 Participants
5 Participants
14 Participants
22 Participants
18 Participants
18 Participants
6 Participants
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related AEs
7 Participants
16 Participants
9 Participants
9 Participants
16 Participants
9 Participants
34 Participants
23 Participants
6 Participants
11 Participants
2 Participants
12 Participants
15 Participants
14 Participants
9 Participants
4 Participants
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related fatal SAEs
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

Number of participants with at least one dose reduction of NIR178 and number of participants with at least one dose interruption of NIR178. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of NIR178
At least one dose reduction
2 Participants
1 Participants
0 Participants
2 Participants
8 Participants
1 Participants
7 Participants
3 Participants
1 Participants
1 Participants
0 Participants
2 Participants
2 Participants
1 Participants
1 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of NIR178
At least one dose interruption
6 Participants
9 Participants
2 Participants
8 Participants
12 Participants
3 Participants
20 Participants
9 Participants
3 Participants
3 Participants
1 Participants
5 Participants
8 Participants
5 Participants
4 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. Dose reductions were not permitted for PDR001.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of PDR001
At least one dose interruption
6 Participants
7 Participants
1 Participants
6 Participants
9 Participants
1 Participants
13 Participants
8 Participants
2 Participants
0 Participants
0 Participants
2 Participants
6 Participants
4 Participants
2 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of PDR001
At least one dose reduction
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

Dose intensity of NIR178 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Dose Intensity of NIR178
316.7 mg/day
Interval 187.0 to 320.0
477.3 mg/day
Interval 321.0 to 480.0
320.0 mg/day
Interval 241.0 to 320.0
295.7 mg/day
Interval 140.0 to 320.0
309.8 mg/day
Interval 141.0 to 320.0
480.0 mg/day
Interval 272.0 to 480.0
320.0 mg/day
Interval 134.0 to 320.0
320.0 mg/day
Interval 179.0 to 320.0
320.0 mg/day
Interval 208.0 to 320.0
320.0 mg/day
Interval 233.0 to 320.0
480.0 mg/day
Interval 363.0 to 480.0
480.0 mg/day
Interval 382.0 to 496.0
320.0 mg/day
Interval 137.0 to 320.0
160.0 mg/day
Interval 96.0 to 173.0
160.0 mg/day
Interval 71.0 to 189.0
320.0 mg/day
Interval 319.0 to 320.0

SECONDARY outcome

Timeframe: Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Dose Intensity of PDR001
394.2 mg/28 days
Interval 300.0 to 400.0
396.2 mg/28 days
Interval 267.0 to 431.0
400.0 mg/28 days
Interval 395.0 to 400.0
393.1 mg/28 days
Interval 350.0 to 400.0
398.2 mg/28 days
Interval 319.0 to 402.0
400.0 mg/28 days
Interval 365.0 to 407.0
400.0 mg/28 days
Interval 236.0 to 405.0
400.0 mg/28 days
Interval 305.0 to 404.0
400.0 mg/28 days
Interval 389.0 to 406.0
400.0 mg/28 days
Interval 386.0 to 400.0
400.0 mg/28 days
Interval 400.0 to 400.0
400.0 mg/28 days
Interval 378.0 to 404.0
400.0 mg/28 days
Interval 224.0 to 406.0
400.0 mg/28 days
Interval 300.0 to 401.0
400.0 mg/28 days
Interval 387.0 to 410.0
400.0 mg/28 days
Interval 400.0 to 400.0

SECONDARY outcome

Timeframe: Up to approximately 5 years

Population: All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001 and had a determinant baseline immunogenicity (IG) sample and at least 1 determinant post-baseline IG sample for assessing anti-PDR001 antibodies. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples * Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples * Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample * ADA-inconclusive: patient who does not qualify for any of the above definitions or a patient for which the baseline sample is missing

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=12 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=24 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=52 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=27 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=10 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=13 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=21 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=19 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=17 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline
11 Participants
23 Participants
12 Participants
13 Participants
24 Participants
11 Participants
49 Participants
27 Participants
13 Participants
10 Participants
6 Participants
13 Participants
21 Participants
19 Participants
17 Participants
6 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at baseline
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
ADA-negative post-baseline
10 Participants
23 Participants
11 Participants
12 Participants
22 Participants
11 Participants
48 Participants
25 Participants
13 Participants
10 Participants
6 Participants
11 Participants
21 Participants
14 Participants
14 Participants
5 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
Treatment-reduced ADA-positive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
Treatment-induced ADA-positive
1 Participants
0 Participants
1 Participants
1 Participants
2 Participants
0 Participants
1 Participants
2 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
5 Participants
3 Participants
1 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
Treatment-boosted ADA-positive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
ADA-inconclusive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: All patients in the Japan safety run-in who either met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations, or had experienced a DLT during Cycle 1.

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with NIR178 as single agent or in combination with PDR001 during the Japan safety run-in part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Japan Safety Run-in: Number of Participants With Dose-Limiting Toxicities (DLTs)
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 0.7 years

Population: All patients from the Japan safety run-in who received at least 1 dose of NIR178 or PDR001.

Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
AEs
3 Participants
3 Participants
3 Participants
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related AEs
0 Participants
2 Participants
1 Participants
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
SAEs
2 Participants
1 Participants
1 Participants
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related SAEs
0 Participants
1 Participants
0 Participants
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Fatal SAEs
0 Participants
0 Participants
0 Participants
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Treatment-related fatal SAEs
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=206 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=54 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=6 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178
Cycle 1 Day 1 (all regimens)
129 ng/mL
Geometric Coefficient of Variation 335.0
160 ng/mL
Geometric Coefficient of Variation 247.8
75.1 ng/mL
Geometric Coefficient of Variation 382.3
81.8 ng/mL
Geometric Coefficient of Variation 99.9
30.1 ng/mL
Geometric Coefficient of Variation 32.9
234 ng/mL
Geometric Coefficient of Variation 70.9
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178
Cycle 1 Day 7 (1 wk-on/1 wk-off)
576 ng/mL
Geometric Coefficient of Variation 83.1
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178
Cycle 1 Day 14 (2 wk-on/2 wk-off)
392 ng/mL
Geometric Coefficient of Variation 212.7
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178
Cycle 1 Day 28 (continuous)
297 ng/mL
Geometric Coefficient of Variation 291.4
622 ng/mL
Geometric Coefficient of Variation 154.3
723 ng/mL
Geometric Coefficient of Variation 295.5
311 ng/mL
Geometric Coefficient of Variation 91.5
167 ng/mL
Geometric Coefficient of Variation 40.9
3760 ng/mL
Geometric Coefficient of Variation 39.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=206 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=54 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=6 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178
Cycle 1 Day 1 (all regimens)
2.00 hours
Interval 0.25 to 8.0
2.13 hours
Interval 0.5 to 8.0
1.50 hours
Interval 0.45 to 4.05
1.50 hours
Interval 1.47 to 1.5
1.50 hours
Interval 0.583 to 3.95
3.00 hours
Interval 2.03 to 3.03
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178
Cycle 1 Day 7 (1 wk-on/1 wk-off)
1.45 hours
Interval 0.5 to 4.0
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178
Cycle 1 Day 14 (2 wk-on/2 wk-off)
1.97 hours
Interval 0.55 to 7.67
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178
Cycle 1 Day 28 (continuous)
2.00 hours
Interval 0.267 to 8.0
2.02 hours
Interval 0.25 to 7.6
1.52 hours
Interval 0.5 to 3.0
1.43 hours
Interval 0.5 to 1.48
1.45 hours
Interval 0.5 to 1.5
2.87 hours
Interval 1.92 to 4.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

PK parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=95 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=24 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=4 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
Cycle 1 Day 1 (all regimens)
295 hr*ng/mL
Geometric Coefficient of Variation 198.3
487 hr*ng/mL
Geometric Coefficient of Variation 126.3
232 hr*ng/mL
Geometric Coefficient of Variation 437.4
170 hr*ng/mL
Geometric Coefficient of Variation 124.9
63.3 hr*ng/mL
Geometric Coefficient of Variation 88.0
550 hr*ng/mL
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
Cycle 1 Day 7 (1 wk-on/1 wk-off)
1260 hr*ng/mL
Geometric Coefficient of Variation 63.2
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
Cycle 1 Day 14 (2 wk-on/2 wk-off)
1680 hr*ng/mL
Geometric Coefficient of Variation 94.4
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
Cycle 1 Day 28 (continuous)
918 hr*ng/mL
Geometric Coefficient of Variation 187.5
1620 hr*ng/mL
Geometric Coefficient of Variation 147.9
938 hr*ng/mL
Geometric Coefficient of Variation 412.2
697 hr*ng/mL
Geometric Coefficient of Variation 131.8
242 hr*ng/mL
Geometric Coefficient of Variation 13.5
12800 hr*ng/mL

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=201 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=54 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=6 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 1 (all regimens)
25.5 ng/mL
Geometric Coefficient of Variation 85.2
33.7 ng/mL
Geometric Coefficient of Variation 64.2
20.1 ng/mL
Geometric Coefficient of Variation 99.2
25.9 ng/mL
Geometric Coefficient of Variation 77.0
28.5 ng/mL
Geometric Coefficient of Variation 99.9
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 7 (1 wk-on/1 wk-off)
62.9 ng/mL
Geometric Coefficient of Variation 39.4
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 14 (2 wk-on/2 wk-off)
71.3 ng/mL
Geometric Coefficient of Variation 43.3
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 28 (continuous)
42.6 ng/mL
Geometric Coefficient of Variation 82.2
77.3 ng/mL
Geometric Coefficient of Variation 49.9
54.1 ng/mL
Geometric Coefficient of Variation 102.4
45.6 ng/mL
Geometric Coefficient of Variation 74.0
53.9 ng/mL
Geometric Coefficient of Variation 64.2
111 ng/mL
Geometric Coefficient of Variation 36.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

NJI765 is a NIR178 metabolite. Pharmacokinetic (PK) parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=201 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=54 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=6 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=2 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 1 (all regimens)
2.00 hours
Interval 0.25 to 8.05
2.08 hours
Interval 0.5 to 8.0
2.10 hours
Interval 0.45 to 4.05
1.95 hours
Interval 0.583 to 2.0
3.00 hours
Interval 2.03 to 3.03
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 7 (1 wk-on/1 wk-off)
1.50 hours
Interval 0.5 to 4.0
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 14 (2 wk-on/2 wk-off)
1.98 hours
Interval 0.55 to 3.0
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 28 (continuous)
2.00 hours
Interval 0.483 to 8.03
2.10 hours
Interval 0.25 to 7.88
0.750 hours
Interval 0.5 to 2.03
2.23 hours
Interval 1.43 to 3.02
1.45 hours
Interval 0.5 to 1.5
2.87 hours
Interval 1.92 to 4.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.

NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=62 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=20 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=2 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=1 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 1 (all regimens)
98.2 hr*ng/mL
Geometric Coefficient of Variation 87.1
122 hr*ng/mL
Geometric Coefficient of Variation 75.6
77.1 hr*ng/mL
Geometric Coefficient of Variation 35.9
117 hr*ng/mL
Geometric Coefficient of Variation 68.2
119 hr*ng/mL
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 7 (1 wk-on/1 wk-off)
243 hr*ng/mL
Geometric Coefficient of Variation 57.5
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 14 (2 wk-on/2 wk-off)
288 hr*ng/mL
Geometric Coefficient of Variation 23.7
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
Cycle 1 Day 28 (continuous)
214 hr*ng/mL
Geometric Coefficient of Variation 76.6
382 hr*ng/mL
Geometric Coefficient of Variation 43.7
226 hr*ng/mL
Geometric Coefficient of Variation 147.0
277 hr*ng/mL
Geometric Coefficient of Variation 69.0
362 hr*ng/mL

SECONDARY outcome

Timeframe: First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=257 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Maximum Observed Serum Concentration (Cmax) of PDR001
First dose (Cycle 1 Day 1 or Cycle 2 Day 1)
93.2 µg/mL
Geometric Coefficient of Variation 30.8
85.0 µg/mL
Geometric Coefficient of Variation 12.8
All Study Parts: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3 Day 1
126 µg/mL
Geometric Coefficient of Variation 37.4
119 µg/mL

SECONDARY outcome

Timeframe: First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=257 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
First dose (Cycle 1 Day 1 or Cycle 2 Day 1)
1.50 hours
Interval 0.333 to 718.0
1.50 hours
Interval 1.48 to 1.52
All Study Parts: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3 Day 1
1.50 hours
Interval 0.55 to 358.0
1.65 hours
Interval 1.65 to 1.65

SECONDARY outcome

Timeframe: First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days

Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=236 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=3 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001
First dose (Cycle 1 Day 1 or Cycle 2 Day 1)
1140 day*µg/mL
Geometric Coefficient of Variation 31.2
1110 day*µg/mL
Geometric Coefficient of Variation 13.9
All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001
Cycle 3 Day 1
2030 day*µg/mL
Geometric Coefficient of Variation 41.3

POST_HOC outcome

Timeframe: On-treatment and safety follow-up (FU) deaths: up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR). Survival FU deaths: up to 4.3 years (Part 1), 5.1 years (Part 2) and 0.9 years (Part 3) and 0.9 years (JSR)

Population: All patients who received at least one dose of study treatment. Patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.

On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 150 days after last dose of NIR178+PDR001. Survival follow-up deaths were collected from 151 days after last dose of NIR178+PDR001 until end of study. All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus survival follow-up deaths.

Outcome measures

Outcome measures
Measure
Part 1: RCC naïve 160 mg
n=11 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC naïve 240 mg
n=23 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy
Part 1: RCC Pre 240 mg
n=14 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy
Part 1: Pancreatic 160 mg
n=14 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer
Part 1: Urothelial 160 mg
n=26 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer
Part 1: H-N naïve 160 mg
n=12 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy
Part 1: H-N Pre 160 mg
n=58 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy
Part 1: MSS CRC wt 160 mg
n=30 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype
Part 1: MSS CRC mu 160 mg
n=16 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant
Part 1: TNBC 160 mg
n=13 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
Part 1: Melanoma Pre 160 mg
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy
Part 1: mCRPC 240 mg
n=15 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 1: mCRPC 240 mg
n=22 Participants
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 Participants
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 Participants
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)
Part 3: TNBC 160 mg Cont
n=6 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)
JSR: 80 mg Cont
n=3 Participants
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 160 mg Cont
n=3 Participants
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in
JSR: 240 mg Cont
n=3 Participants
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in
All-Collected Deaths
On-treatment and post-treatment safety follow-up deaths
4 participants
6 participants
10 participants
6 participants
8 participants
4 participants
22 participants
9 participants
7 participants
9 participants
2 participants
2 participants
6 participants
4 participants
6 participants
4 participants
2 participants
0 participants
1 participants
All-Collected Deaths
Survival follow-up deaths
3 participants
7 participants
3 participants
4 participants
12 participants
4 participants
22 participants
12 participants
8 participants
2 participants
3 participants
7 participants
8 participants
9 participants
7 participants
1 participants
1 participants
All-Collected Deaths
All deaths
7 participants
13 participants
13 participants
10 participants
20 participants
8 participants
44 participants
21 participants
15 participants
11 participants
5 participants
9 participants
14 participants
13 participants
13 participants
5 participants
2 participants
0 participants
2 participants

Adverse Events

Part 1: RCC naïve 160 mg

Serious events: 3 serious events
Other events: 10 other events
Deaths: 4 deaths

Part 1: RCC naïve + Pre 240 mg

Serious events: 7 serious events
Other events: 22 other events
Deaths: 6 deaths

Part 1: Pancreatic 160 mg

Serious events: 9 serious events
Other events: 14 other events
Deaths: 10 deaths

Part 1: Urothelial 160 mg

Serious events: 7 serious events
Other events: 14 other events
Deaths: 6 deaths

Part 1: H-N naïve + Pre 160 mg

Serious events: 16 serious events
Other events: 25 other events
Deaths: 8 deaths

Part 1: H-N Pre 240 mg

Serious events: 5 serious events
Other events: 12 other events
Deaths: 4 deaths

Part 1: MSS CRC 160 mg

Serious events: 28 serious events
Other events: 52 other events
Deaths: 22 deaths

Part 1: TNBC 160 mg

Serious events: 14 serious events
Other events: 29 other events
Deaths: 9 deaths

Part 1: Melanoma naïve + Pre 160 mg

Serious events: 4 serious events
Other events: 14 other events
Deaths: 7 deaths

Part 1: DLBCL 160 mg

Serious events: 7 serious events
Other events: 13 other events
Deaths: 9 deaths

Part 1: DLBCL 240 mg

Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths

Part 1: mCRPC 240 mg

Serious events: 5 serious events
Other events: 14 other events
Deaths: 2 deaths

Part 2: NSCLC 160 mg Cont

Serious events: 11 serious events
Other events: 22 other events
Deaths: 6 deaths

Part 2: NSCLC 160 mg 2wk-on/2wk-off

Serious events: 9 serious events
Other events: 16 other events
Deaths: 4 deaths

Part 2: NSCLC 160 mg 1wk-on/1wk-off

Serious events: 7 serious events
Other events: 17 other events
Deaths: 6 deaths

Part 3: TNBC 160 mg Cont

Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths

JSR: 80 mg Cont

Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths

JSR: 160 mg Cont

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

JSR: 240 mg Cont

Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths

Part 1: RCC naïve 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Part 1: RCC naïve + Pre 240 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths

Part 1: Pancreatic 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Part 1: Urothelial 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Part 1: H-N naïve + Pre 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths

Part 1: H-N Pre 240 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Part 1: MSS CRC 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths

Part 1: TNBC 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths

Part 1: Melanoma naïve + Pre 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

Part 1: DLBCL 160 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Part 1: DLBCL 240 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Part 1: mCRPC 240 mg_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths

Part 2: NSCLC 160 mg cont_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

Part 2: NSCLC 160 mg 2wk-on/2wk-off_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths

Part 2: NSCLC 160 mg 1wk-on/1wk-off_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths

Part 3: TNBC 160 mg cont_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

JSR: 80 mg cont_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

JSR: 160 mg cont_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

JSR: 240 mg cont_Survival Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Part 1: RCC naïve 160 mg
n=11 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: RCC naïve + Pre 240 mg
n=23 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Pancreatic 160 mg
n=14 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Urothelial 160 mg
n=14 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: H-N naïve + Pre 160 mg
n=26 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: H-N Pre 240 mg
n=12 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: MSS CRC 160 mg
n=58 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: TNBC 160 mg
n=30 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Melanoma naïve + Pre 160 mg
n=16 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: DLBCL 160 mg
n=13 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: DLBCL 240 mg
n=6 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: mCRPC 240 mg
n=15 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg Cont
n=22 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 participants at risk
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 participants at risk
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 3: TNBC 160 mg Cont
n=6 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 80 mg Cont
n=3 participants at risk
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 160 mg Cont
n=3 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 240 mg Cont
n=3 participants at risk
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: RCC naïve 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: RCC naïve + Pre 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Pancreatic 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Urothelial 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: H-N naïve + Pre 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: H-N Pre 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: MSS CRC 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: TNBC 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Melanoma naïve + Pre 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: DLBCL 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: DLBCL 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: mCRPC 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg 2wk-on/2wk-off_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg 1wk-on/1wk-off_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 3: TNBC 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 80 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 240 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Blood and lymphatic system disorders
Anaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Cardiac failure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Atrial tachycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Myocardial infarction
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Autoimmune myocarditis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Pericardial effusion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Adrenal insufficiency
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Hyperthyroidism
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Eye disorders
Blindness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Eye disorders
Gaze palsy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Abdominal pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Ascites
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Colonic fistula
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Constipation
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Diarrhoea
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Dysphagia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Ileus
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Nausea
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Pancreatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Vomiting
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Chest pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Disease progression
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Face oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Fatigue
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
General physical health deterioration
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Generalised oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Oedema peripheral
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Pyrexia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Autoimmune hepatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Cholangitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Cholecystitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatic failure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatic haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Immune-mediated hepatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Liver disorder
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Bronchitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Cellulitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Encephalitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Enterocolitis infectious
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Herpes zoster
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Influenza
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Large intestine infection
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Peritonitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Pleural infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Cerebral infarction
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Pneumonia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Pneumonia aspiration
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Scrotal abscess
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Sepsis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Urinary tract infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Urogenital infection bacterial
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Vascular device infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Fall
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Multiple injuries
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Overdose
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Alanine aminotransferase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Amylase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Aspartate aminotransferase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood bilirubin increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood creatine phosphokinase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood creatinine increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Electrocardiogram QT prolonged
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
General physical condition abnormal
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Hepatic enzyme increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Lipase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Troponin I increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypervolaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Autoimmune myositis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Sacral pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary tumour thrombotic microangiopathy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Cerebrospinal fluid leakage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Cerebrovascular accident
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Migraine
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Paraesthesia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Acute kidney injury
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Seizure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Spinal cord compression
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Syncope
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Haematuria
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Renal impairment
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Female genital tract fistula
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Peyronie's disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Hydrothorax
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Aortic aneurysm
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.

Other adverse events

Other adverse events
Measure
Part 1: RCC naïve 160 mg
n=11 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: RCC naïve + Pre 240 mg
n=23 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Pancreatic 160 mg
n=14 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Urothelial 160 mg
n=14 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: H-N naïve + Pre 160 mg
n=26 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: H-N Pre 240 mg
n=12 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: MSS CRC 160 mg
n=58 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: TNBC 160 mg
n=30 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: Melanoma naïve + Pre 160 mg
n=16 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: DLBCL 160 mg
n=13 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: DLBCL 240 mg
n=6 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: mCRPC 240 mg
n=15 participants at risk
NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg Cont
n=22 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg 2wk-on/2wk-off
n=20 participants at risk
NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 2: NSCLC 160 mg 1wk-on/1wk-off
n=20 participants at risk
NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001
Part 3: TNBC 160 mg Cont
n=6 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 80 mg Cont
n=3 participants at risk
NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 160 mg Cont
n=3 participants at risk
NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
JSR: 240 mg Cont
n=3 participants at risk
NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001
Part 1: RCC naïve 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: RCC naïve + Pre 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Pancreatic 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Urothelial 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: H-N naïve + Pre 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: H-N Pre 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: MSS CRC 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: TNBC 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: Melanoma naïve + Pre 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: DLBCL 160 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: DLBCL 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 1: mCRPC 240 mg_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg 2wk-on/2wk-off_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 2: NSCLC 160 mg 1wk-on/1wk-off_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Part 3: TNBC 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 80 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 160 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
JSR: 240 mg cont_Survival Period
Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.
Blood and lymphatic system disorders
Anaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
35.7%
5/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
19.2%
5/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
18.8%
3/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
3/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Lymphadenitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
3/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Toothache
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Vomiting
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.7%
12/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
5/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
22.7%
5/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Atrial fibrillation
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Bradycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Extrasystoles
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Cardiac failure congestive
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Coronary artery disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Palpitations
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Pericardial effusion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Sinus bradycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Sinus tachycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Cardiac disorders
Tachycardia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Ear and labyrinth disorders
Vertigo
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Adrenal insufficiency
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Hyperthyroidism
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Hypothyroidism
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Endocrine disorders
Lymphocytic hypophysitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Eye disorders
Cataract
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Eye disorders
Photopsia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Eye disorders
Vision blurred
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Abdominal distension
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.0%
3/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Abdominal pain
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.5%
9/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.3%
6/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Ascites
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Constipation
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.4%
7/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.5%
9/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
3/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
36.4%
8/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
40.0%
8/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Dental caries
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Diarrhoea
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
34.8%
8/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.7%
12/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
3/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
18.2%
4/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
50.0%
3/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Dry mouth
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Dyspepsia
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Dysphagia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Faeces soft
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Flatulence
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
19.2%
5/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Haematochezia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Ileus
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Nausea
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.7%
5/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
35.7%
5/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
6/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
2/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
22.4%
13/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.0%
9/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
4/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
5/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
22.7%
5/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
66.7%
4/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Retching
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Gastrointestinal disorders
Stomatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Administration site bruise
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Asthenia
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.7%
5/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
5/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
4/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Axillary pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Catheter site oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Chest discomfort
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Chest pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Chills
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Discomfort
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Face oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Fatigue
36.4%
4/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.7%
5/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
35.7%
5/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
42.3%
11/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
3/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
34.5%
20/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
10/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
18.8%
3/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
26.7%
4/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
50.0%
11/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.0%
6/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
5/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
50.0%
3/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Feeling of body temperature change
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Gait disturbance
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
General physical health deterioration
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
SARS-CoV-2 test negative
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Influenza like illness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Malaise
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Non-cardiac chest pain
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Oedema peripheral
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
12.5%
2/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Peripheral swelling
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Pyrexia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.5%
9/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.0%
9/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.8%
4/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
General disorders
Swelling face
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Cholestasis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatic failure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hepatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Immune-mediated hepatitis
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Hepatobiliary disorders
Jaundice
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Abdominal abscess
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Body tinea
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
COVID-19
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Device related infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Diarrhoea infectious
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Escherichia sepsis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Eye infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Gastroenteritis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Herpes zoster
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Influenza
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Nasopharyngitis
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Oesophageal candidiasis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Oral candidiasis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Pharyngitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Pneumonia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Rash pustular
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Tinea versicolour
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Tonsillitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Tracheitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Upper respiratory tract infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Urinary tract infection
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Urinary tract infection enterococcal
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Urogenital infection bacterial
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Vaginal infection
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Infections and infestations
Viral infection
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Fall
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Wound complication
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Injury, poisoning and procedural complications
Wound necrosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
SARS-CoV-2 test positive
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Alanine aminotransferase increased
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
19.0%
11/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.0%
9/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
3/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Amylase increased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
26.7%
4/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Aspartate aminotransferase increased
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
24.1%
14/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
30.0%
9/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
3/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Bilirubin conjugated increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood alkaline phosphatase increased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood bilirubin increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood creatine phosphokinase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Eosinophil count increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood creatinine increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
12.5%
2/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood phosphorus increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
C-reactive protein increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Electrocardiogram QT prolonged
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Gamma-glutamyltransferase increased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.3%
6/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Haemoglobin decreased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Human chorionic gonadotropin increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
International normalised ratio increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Lipase increased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
26.7%
4/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Lymphocyte count decreased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
66.7%
2/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Oxygen saturation decreased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Platelet count decreased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Transaminases increased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Investigations
Weight decreased
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Cachexia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Decreased appetite
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.0%
3/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
50.0%
7/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
35.7%
5/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
6/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
29.3%
17/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
12.5%
2/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
3/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
27.3%
6/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
5/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
66.7%
2/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Dehydration
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Glucose tolerance impaired
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypercalcaemia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.0%
3/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyperglycaemia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyperlipasaemia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyperuricaemia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypoalbuminaemia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
23.1%
3/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Obesity
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Amyotrophy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Arthralgia
27.3%
3/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.5%
9/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
26.7%
8/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Back pain
27.3%
3/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.7%
5/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.4%
3/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
3/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Fracture pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Joint stiffness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Mobility decreased
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Muscle atrophy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.6%
5/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Myalgia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
2/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
3/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Osteoarthritis
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
18.8%
3/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Musculoskeletal and connective tissue disorders
Trismus
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Hypoaesthesia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Amnesia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Anosmia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Aphasia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Autonomic nervous system imbalance
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Dizziness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
35.7%
5/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Dysaesthesia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Dysgeusia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Headache
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
2/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
4/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
18.2%
4/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Migraine
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Neuropathy peripheral
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Paraesthesia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Presyncope
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Sciatica
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Seizure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Somnolence
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Taste disorder
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Nervous system disorders
Tremor
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Anxiety
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Confusional state
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Depression
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Hallucination
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Insomnia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.0%
3/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.9%
4/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Mood altered
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Panic disorder
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Restlessness
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Sleep disorder
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Psychiatric disorders
Stress
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Acute kidney injury
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Azotaemia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Bladder pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Dysuria
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Haematuria
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Leukocyturia
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Nocturia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Urethral pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Renal and urinary disorders
Urinary retention
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Balanoposthitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Benign prostatic hyperplasia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Breast oedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Breast pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
2/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Intermenstrual bleeding
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Pelvic pain
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Peyronie's disease
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
4/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
19.0%
11/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
10/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
27.3%
6/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
28.6%
4/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.8%
8/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
6/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
22.7%
5/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
25.0%
5/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
20.0%
4/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Rhinalgia
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Sputum retention
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Lymphoedema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Acne
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Alopecia
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Raynaud's phenomenon
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Dry skin
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
9.1%
2/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Intertrigo
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Pemphigoid
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Pruritus
27.3%
3/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.7%
2/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
2/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.8%
8/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
3/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
12.5%
2/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
22.7%
5/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.0%
3/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Rash
18.2%
2/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
21.7%
5/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
11.5%
3/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.2%
3/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
15.4%
2/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
26.7%
4/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.6%
3/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
10.0%
2/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Scar pain
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Skin and subcutaneous tissue disorders
Vitiligo
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.2%
1/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Angiopathy
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Flushing
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Haematoma
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.3%
1/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Hot flush
9.1%
1/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
1.7%
1/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
1/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
16.7%
1/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Hypertension
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.3%
1/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.8%
1/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
3.4%
2/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
6.7%
2/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
13.3%
2/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
33.3%
1/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Hypotension
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.1%
1/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
8.3%
1/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
7.7%
1/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
4.5%
1/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
5.0%
1/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
Vascular disorders
Superficial vein thrombosis
0.00%
0/11 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/23 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
14.3%
2/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/14 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/26 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/12 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/58 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/30 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/16 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/13 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/15 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/22 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/20 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/6 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0.00%
0/3 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.
0/0 • On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).
Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER